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A Proposal for a Comprehensive Quality Overall Summary

ISPE

TPP/QTPP and Definition of CQAs As illustrated above, a development narrative briefly summarizes the quality elements of the product that are designed to meet patient needs (TPP and QTPP) and is organized based on the product understanding, risk assessments, and development data used to justify the control strategy.

article thumbnail

A Proposal for a Comprehensive Quality Overall Summary

ISPE

TPP/QTPP and Definition of CQAs As illustrated above, a development narrative briefly summarizes the quality elements of the product that are designed to meet patient needs (TPP and QTPP) and is organized based on the product understanding, risk assessments, and development data used to justify the control strategy.

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Environmental Sustainability in Biopharmaceutical Facility Design

ISPE

linear) design process is central to successfully attaining such comprehensive sustainability goals and project needs (see Figure 1). query=environment Labeling and Organization There are various ways to group the many types of environmental sustainability challenges and goals. 7 An integrative (vs. Accessed 3 December 2022.